General Device Labeling Requirements

General Labeling Provisions

The general labeling requirements for medical devices are contained in 21 CFR Part 801. These regulations specify the minimum requirements for all devices. Later sections in this chapter discuss any additional requirements needed for specific categories of devices.

If a packer, distributor, or seller intends a device for uses other than those intended by the person from whom he received the device, these parties must furnish adequate labeling in accordance with the new intended use.

If a manufacturer knows or has information indicating that this device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)

A word, statement or other required information may lack the required prominence and conspicuousness for the following reasons:

If it fails to appear on the part or panel that is displayed under customary conditions of purchase;

If the package contains sufficient space and the required information fails to appear on two or more panels, each of which is designed to render it to be displayed under customary conditions of purchase;

Failure to extend required labeling over package space provided;

Lack of sufficient label space for required labeling due to placement of non-required labeling of the package; or

Smallness or style of type, insufficient contrast between labeling and package background, designs which obscure labeling, or overcrowding of labeling shich renders it unreadable.

Exemptions

Exemptions may be granted in those instances where device labeling lacks sufficient space for required labeling provided that:

Existing label space is not taken up by including non-required information or by giving prominence to a portion of the required labeling; andExisting label space is not used for any representations in a foreign language.All labeling shall be in English with the exception of products distributed solely within Puerto Rico or a U.S. territory where the predominant language is other than English. In these instances the predominant language may be substituted for English.

If any representation on the device label or labeling appears in a foreign language, then all required labeling shall also appear in that foreign language.